- Aequor (Devers, TX)
- Sr . Director , IT Cell Therapy Devens Manufacturing Site (DVN 2024) Salary Range: $223K to $262K &plus 25% annual Bonus &plus Long-term incentives of 85000 ... Position Summary The Sr . Director , Cell Therapy Devens Manufacturing Site...process automation systems, MES, LIMS, application integrations, local manufacturing, quality control and quality management site IT… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: This role is responsible for providing regulatory strategic and tactical leadership, and alignment to ways of working on ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …changing lives for a living. Are you ready to make a difference? The Position As Senior Medical Director for the novel modalities team, you will be part of ... Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe Sr . Director of Technical Transfer is responsible for activities related to technology transfer from external and internal customers. This ... process qualification, packaging and labeling. This position will interface with Operations, Regulatory , Quality Assurance, Finance, R&D, Project Management and … more
- Genmab (Plainsboro, NJ)
- …As part of our expanding US Medical Affairs (USMA) team, Genmab is seeking a Senior Director , USMA Solid Tumor Portfolio. This role will report to the VP/Head ... to requests for information, consistent with promotional compliance and regulatory requirementsDevelops and maintains a network of cooperative groups, medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with decision-makers across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential ... regulatory strategy for assigned programs to ensure timely and high- quality regulatory deliverables to the GPTs Lead health authority interactions, including… more
- Merck & Co. (Rahway, NJ)
- …of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …needs and the respective development stage of the project. The CMC Lead will support the Sr . CMC Lead on complex and/or late-stage project or act as main CMC Lead of ... smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …make a difference? The Position Reporting to the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as we embark on shaping our future. The Position The Associate Director , HCP Experience has overall strategic and operational responsibility as well as ... Reports to the Hemophilia Therapy Area Lead. Works closely with Associate Directors and Sr Brand Managers across the Rare Bleeding TA and with individuals in similar… more
- Merck & Co. (Millsboro, DE)
- …DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report to the Site Quality Head/ ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...facilitating communication between the Animal Services team and the Quality organization. This position will work in close coordination… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technologies/ Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of ... research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to exercise… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key ... merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both...within the US East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and … more
- Merck & Co. (North Wales, PA)
- …under the guidance of the Associate Director who supports the Global Regulatory Affairs & Clinical Safety (GRACS) and Quality Assurance (QA) organizations ... Job Description Position Description: Senior Specialist, Financial Planning & Analysis Our company's...analytical support to our Research & Development Division, Global Regulatory Affairs & Clinical Safety (GRACS), and QA organizations.Forecast… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The Role & Department As a Senior Programming Associate or Programming Manager, you will be in the Statistical ... integrity, consistency, and adherence to standards, and ensuring well-structured, high quality data summaries for internal decision making and reporting to health… more
- Genmab (Plainsboro, NJ)
- …alignment with the global development strategy. Works in collaboration with a Medical Director and Sr . level Clinical Research Scientist as indicated for ongoing ... a less-complex clinical trial(s) within a program.Works in collaboration with a Medical Director and Sr . level Clinical Research ScientistAssists to execute the… more
- Novo Nordisk Inc. (Milwaukee, WI)
- …coordination with his/er Field Director . Relationships Position reports to Field Director / Senior Field Director . Serves as organization spokesperson on ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory , Technical Operations and RNAi Early Development professionals at ... disruptions to our patients Work effectively across all departments, such as Quality Assurance/ Control, Chemical Development, Program Management, Regulatory , … more
